Vascular access devices and methods

Abstract

The present disclosure relates to implantable vascular access devices. The present disclosure also relates to methods and kits comprising such vascular access devices and delivery systems for delivering such devices to suitable implant sites. The present disclosure also relates to methods for implanting such devices and methods for positioning such devices after implantation.

Description

[0001] This disclosure claims the benefit of European patent application EP22382775.9 filed on August 10, 2022. Technical Field

[0002] The present disclosure relates to implantable medical devices, and more particularly to implantable vascular access devices. The present disclosure also relates to methods for positioning and accessing implanted vascular access devices, and methods for implanting and positioning such devices. Background Art

[0003] Vascular access systems are known for providing repeated access to a patient's body during treatment or for diagnostic purposes. For example, the use of such implants is known in tumor treatment. The implant typically comprises an interface closed by a diaphragm and a catheter connected to the interface. The interface can be implanted in a "pouch" formed under the patient's skin in the patient's chest area.

[0004] The catheter can be connected to the patient's jugular vein, subclavian vein, or other major vein that drains into the vena cava (usually the superior vena cava). The needle can be used to inject a therapeutic substance (e.g., a chemotherapeutic agent) into the interface to deliver it to the body. In addition, the needle can be used to draw blood from a shallow tissue area in the patient's body, such as subcutaneously under the skin, for diagnostic or analytical purposes.

[0005] Although the interface can be quite small, depending on the patient's age and body type, the interface may be seen as an area protruding from the patient's chest.

[0006] A sharp incision, for example, about 2 cm or 2.5 cm, must be made to create a subcutaneous pocket for insertion of the implant.

[0007] To perform an injection, the medical professional will rely on palpation techniques to locate the port. Even once the port has been located, the professional still cannot see the septum to be pierced for access. A commonly used technique is to press down on the port during or prior to the injection to ensure that the port does not move.

[0008] In order to enhance the process of locating and entering the interface, it is known to provide an interface with a plurality of small protrusions. Identifying these protrusions can reduce errors when inserting the needle. WO 2007 / 041471 provides a plurality of LEDs and light guides to provide a plurality of visual indicators around the septum of the interface to facilitate entry into the interface. The LEDs can be activated by pushing the interface. Although such devices have been commercialized, they have been withdrawn from the market due to their significant side effects associated with extrusion and infection of the device.

[0009] DE 10 2015 122 061 discloses an interface having a plurality of optical modules.

[0010] Complications of using different ports include large scars, surgical wound infection, and extrusion of the device. Other common complications include incorrect injection (i.e., not in the injection port, but close to the injection port). This can cause pain and anxiety to the patient, increased risk of catheter infection, and bruising. This is particularly traumatic for pediatric patients.

[0011] Undetected access errors result in the infusion of medication outside the reservoir (subcutaneous cell tissue), with serious consequences in the case of extremely irritating drugs that may cause skin necrosis and require the removal of the device and replacement with another one. Access errors increase the risk of infection exponentially because more frequent handling leads to a greater risk of infection. Injection port infection is a serious complication (catheter sepsis) that is usually unresponsive to antibiotic treatment. When this occurs, the device may need to be removed after the surgical procedure in the operating room, which is usually accompanied by local or general anesthesia. Surgical procedures in pediatric patients require general anesthesia, which may also increase patient anxiety. In addition, repeated general anesthesia procedures increase the risk of neurological disorders.

[0012] Furthermore, use of the interface may be uncomfortable and even traumatic for the patient due to aesthetic aspects, discomfort during movement, and even normal activities (eg, putting on a car's seat belt).

[0013] The present disclosure aims to provide methods and apparatus that avoid or at least reduce one or more of the above-mentioned disadvantages. Summary of the invention

[0014] In one aspect of the present disclosure, an implantable vascular access device is provided. The device includes a housing, a reservoir having an outlet lumen, a diaphragm for closing the reservoir and defining an injection area, a visualization system for visualizing the injection area, and a controller configured to actuate the visualization system. The implantable vascular access device is self-detaching.

[0015] According to this aspect, a self-detaching implantable vascular access device is provided. Self-detaching as used throughout this disclosure may be understood to refer to such a device, i.e., a device whose shape and size are such that no specific detachment is required to create a space for implantation or positioning. Although the interface of the prior art requires a bag to be formed under the skin and typically under the subcutaneous fat tissue, the vascular access device according to this aspect does not require such a bag. The ability to be introduced under the subcutaneous tissue without detachment is typically a combination of size and shape. In particular, the size of the implantable vascular device may typically be smaller than that of the device of the prior art, and in an example, the outer shape of the vascular access device may have a tapered portion. Along the tapered portion, the width and / or height may gradually increase to facilitate gradual introduction. Bumps, steps, protrusions may typically be avoided along the outer surface, specifically along the tapered portion.

[0016] In an example, a vascular access device can be significantly smaller than hitherto known interfaces. Since the vascular access device according to this aspect is significantly smaller, it is generally not visible from the outside and is more comfortable for the patient. However, when the device is to be positioned, for example when an injection is to be given or a blood sample is to be drawn, the device is not easily palpable or visible from the outside. To this end, the vascular access device according to this aspect includes a visualization system and a controller that activates the visualization system to help a professional (doctor, surgeon, nurse) position the device so that palpation is not required.

[0017] According to a second aspect, an implantable vascular access device is provided, comprising a housing, a reservoir having an outlet lumen, a diaphragm for sealing the reservoir and defining an injection area, and one or more sensors arranged to measure one or more parameters of blood in the reservoir. The implantable vascular access device also includes a transmitter for transmitting the measured parameters. According to this aspect, an implantable vascular access device is provided that can be used to obtain measurement results remotely. Since the implantable vascular access device is directly connected to the patient's blood vessels, measurements can be taken by the sensor and the data obtained can then be sent. Therefore, there is no need or little need for professionals to puncture the patient to obtain a sample for analysis. Therefore, the patient experiences less trauma, particularly for children.

[0018] In an example, these sensors may be configured to measure one or more of: body temperature, heart rate, oxygen saturation, blood glucose, PCR sensor, pH, lactate, etc.

[0019] The first aspect and the second aspect may also be combined.

[0020] In some examples, the height of the device can be less than 10 mm, specifically less than 8 mm, and more specifically 6 mm or less. Since the device does not need to be palpated for positioning, the device can be made as small as possible, specifically as "flat" as possible. In an example, the height of the device can depend on the size of the catheter attached to the interface, and the height of the device can be simply the height required for coupling the catheter.

[0021] In some examples, the injection area may have a 75 mm 2 or larger, specifically 85mm 2 or larger, more specifically 95mm 2 or larger. Although it is generally desirable to minimize the size of a vascular access device, the most important dimension in terms of patient comfort may be the height of the vascular access device. To make injections safer and / or to make the device more durable, the injection area may actually be larger than in the prior art. Since increasing the injection area also reduces the need for repeated needle punctures at the same location, scarring may be reduced.

[0022] In some examples, the width of the vascular device can be 12 mm or less, specifically 10 mm or less, and more specifically 8 mm or less or even 5 mm or less. The reduction in width can reduce the size of the injection area. The minimum width of a currently commercially available pediatric vascular access device is 19 mm. A width of 12 mm allows for a skin incision of 10 mm or less. This size also allows for tunneling and self-cutting with a specific tunneler, which will be disclosed below.

[0023] For smaller skin incisions and even easier tunneling, a width of 8 mm or less is desirable. A width of 5 mm or less improves this even further and can be achieved, for example, by increasing the length of the device, as this will maintain or even increase the injection area.

[0024] Since the device according to examples of the present disclosure is generally unnoticeable under the skin due to its limited height and due to the visualization system, these dimensions can be varied. Specifically, the length of the vascular access device can be increased to increase the size of the injection area without otherwise adversely affecting performance.

[0025] In an example, the length of the vascular access device can be 30 mm or more, specifically 35 mm or more, more specifically 40 mm or more, or even 50 mm or more. In an example, a vascular access device according to the present disclosure can be much longer than a vascular access device in the prior art. The increase in the length of the vascular access device can be achieved in particular by a tapered portion of significant length. The tapered portion can have a tapered height and / or a tapered width.

[0026] In an example, the visualization system can be configured to indicate the perimeter of the injection area. The visualization system can be arranged, for example, along the perimeter of the injection area. The nurse or other professional then simply needs to ensure that the puncture is within the perimeter. Errors during injection and corresponding complications for the patient can be avoided or reduced.

[0027] In an example, the visualization system may be configured to indicate the puncture site within the injection region, ie provide the medical professional with some indication that the puncture should preferably be performed within the injection region. The appropriate puncture point may be varied to avoid wear or degradation of a particular portion of the septum.

[0028] In some examples, the visualization system includes one or more light emitting devices arranged along the perimeter of the injection area. Suitable light emitting diodes can be used to transmit light when activated, and the transmitted light can be visible through the patient's skin. Multiple LEDs can be arranged along the perimeter of the injection area. In an example, the LEDs used can be millimeters (the width or diameter of the LEDs can be, for example, 1-3mm). Multiple LEDs can be used to mark the boundaries of the injection area. Alternatively, a ring-shaped LED can be used to indicate the circumference of the injection area. The use of multiple light emitting devices such as LEDs can also be used to extend the needle puncture over the injection area.

[0029] In a further example, the visualization system includes an augmented reality device. The nurse (or other professional) can wear appropriate glasses with an augmented reality system. When the visualization system is activated, the location of the vascular access device (or specifically, the injection area) can be projected onto the patient's skin, thereby facilitating puncturing the septum of the device.

[0030] In examples, the device may also include an energy source, optionally including a battery. In other examples, power / energy may be provided remotely, such as when activated by another device. For example, wireless power transmission may be used.

[0031] In an example, the controller may be configured to activate the visualization system after receiving an instruction from a remote controller. Such a remote controller may be, for example, a PDA, a tablet computer, or a smart phone. When it is necessary to enter the device, the remote controller may transmit an instruction to the controller to activate the visualization system. The visualization may be programmed in various ways and may be programmed to illuminate the injection area (or its periphery) for a predetermined period of time, which may be, for example, 1 minute or 2 minutes, or any other amount of time suitable for the procedure to be completed. After the predetermined period of time, the visualization system may be turned off. Thus, power consumption may be appropriately reduced.

[0032] The same PDA, tablet or smartphone can also be used to obtain measured variables from sensors (if available).

[0033] In some examples, an outlet lumen is disposed at a first end of the device, and the device may further include a device-side connector for releasably coupling to a connector of a delivery system.The vascular access device may be pulled or dragged toward a suitable site.

[0034] In some examples, the device-side connector can be an eye or eyelet configured to receive a hook of the delivery system. In other examples, the device-side connector is a connector for magnetically coupling to a connector of a delivery system.

[0035] In another aspect, a system is provided, comprising a vascular access device according to any example and further comprising a data processing system comprising a receiver for receiving data transmitted by a transmitter of the device and a database for storing the received data.

[0036] In an example, such a system may also include a display for visualizing the received data. In an example, the data processing system may be a personal computer, a tablet computer, a mobile phone, a smart phone, or a personal digital assistant. Any other suitable data processing system may be used.

[0037] In an example, the data processing system can not only receive data from the sensor and further process such data, or send such data for further processing, but the data processing system can also be used to transmit instructions to the vascular access device. For example, instructions for measuring and / or instructions for activating a visualization system can be transmitted from such a system.

[0038] In some examples, the data processing system can store the data for further processing and / or upload the data to a hospital portal or another website. If necessary, the patient and / or other medical professionals can access the data. In other examples, the data can be transmitted to the patient's smartphone or a guardian or representative of the patient. The user can download an appropriate application to access and visualize the data.

[0039] In yet another aspect, a kit is provided, the kit comprising an implantable vascular access device according to any of the embodiments disclosed herein, and a remote controller for transmitting one or more commands to a controller of the implantable vascular access device.

[0040] The remote control may be a personal computer, a tablet, a mobile phone, a smartphone or a personal digital assistant. Such a remote control may be used to transmit instructions, request measurement data if sensors are provided, activate a visualization system, etc. In some examples, the remote control may be integrated in the needle. Due to the proximity of the needle, a visualization system may be activated.

[0041] In yet another aspect, a method for locating a vascular access device implanted in a patient is provided. The method includes remotely activating a visualization system of the vascular access device to visualize a perimeter of an injection area of ​​the vascular access device, and locating the vascular access device by detecting the perimeter of the injection area.

[0042] According to this aspect, a practitioner can identify a vascular access device and injection area of ​​such a device without palpation. This allows the vascular access device to be generally smaller and, in particular, flatter than prior art devices.

[0043] In an example, when the visualization system is not activated, the vascular access device is not visible at all from outside the patient. In an example, the vascular access device is virtually impossible to locate by palpation.

[0044] In yet another aspect, a delivery system for delivering a vascular access device is provided. The vascular access device has a first end and a second end, and an outlet lumen having a device-side connector for coupling to a catheter disposed at the first end. The delivery system includes a tunneler configured to provide a tunnel between a first access site and a second access site, wherein the tunneler is further configured to releasably couple to the vascular access device at the second end of the vascular access device.

[0045] According to this aspect, a delivery system is provided that enables implantation of a vascular access device into a suitable implantation site without the need to form a pocket. The invention provides a delivery system that is particularly suitable for implanting a vascular access device that is generally of reduced size. The tunnel created subcutaneously can be occupied by a catheter attached to the vascular access device. Tissue growth around the catheter may then occur.

[0046] The first access site herein can be considered a venous access site. The second access site is comparable to a device access site in the prior art. However, in the examples of the present disclosure, such a traditional device access site is not required.

[0047] Throughout this disclosure, tunneling may be understood as the creation of a subcutaneous passage. A tunneler (also referred to as a "vascular tunneler" or "tunneler") is a device configured for tunneling. A tunneler may generally include a tubular body and a "tunneling" tip, wherein the tip separates tissue to create a tunnel.

[0048] In an example, the tunneler can be configured to release the vascular access device at a location between the first access site and the second access site. The tunneler can be used to pull the vascular access device from the first access site to the second access site and then release the vascular access device at a predetermined location.

[0049] The first entry site may be a vascular access point, i.e., in or near the patient's neck or subclavian region. The second entry site may be in the patient's axillary region. Since no interface is formed and only a very small incision is required, only a small scar is left, and thus a suitable entry site may be selected without regard to aesthetic appearance.

[0050] In yet another aspect, a method for delivering a vascular access device to an implantation site is provided. The method includes setting a first access site through the skin of a patient, introducing a catheter into a vein through the first access site, setting a second access site through the skin of the patient, and setting a tunnel between the first access site and the second access site using a tunneler. The method also includes releasably coupling the tunneler to the vascular access device, moving the tunneler from the first access site toward the second access site to pull the vascular access device toward the second access site, and releasing the vascular access device at the implantation site.

[0051] In some examples, setting up a passage between the first access site and the second access site and pulling the vascular access device toward the second access site can be performed simultaneously, that is, a tunnel is formed from the first access site to the second access site, and at the same time, the vascular access device (with the catheter coupled thereto) is pulled to the desired site.

[0052] In other examples, a tunneler can be used to set a tunnel from a second access site to a first access site.The tunneler can then be releasably coupled to a vascular access device (including a catheter), and the tunneler can be moved from the first access site to the second access site.

[0053] In an example, providing a second entry site includes forming an incision in the skin, wherein the incision may be less than 0.5 cm in length, specifically less than 3 mm in length, and more specifically 2 mm or less in length. In prior art systems and methods, a relatively large incision may be required at the second entry site (implantation site near the interface) because a relatively large interface is introduced there and a pocket is created. In examples of the present disclosure, the interface may be significantly smaller, and only a tunneler may enter and exit the skin from the second entry site. This may result in less scarring.

[0054] In some examples, the tunneler can be releasably mechanically coupled to the vascular access device. In other examples, magnetic coupling or other alternatives can be used.

[0055] In some examples, the method can include visualizing the vascular access device and / or catheter as the vascular access device is pulled from the first access site to the second access site. Optionally, X-ray visualization of the catheter position in the vein can be used to ensure proper catheter placement. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Non-limiting examples of the present disclosure will now be described with reference to the accompanying drawings, in which:

[0057] Figures 1A to 1E schematically illustrates a first example of a vascular access device according to the present disclosure;

[0058] FIG. 2A to FIG. 2CAnother example of a vascular access device is shown;

[0059] FIG. 3A to FIG. 3C An example of a delivery system for a vascular access device is schematically illustrated;

[0060] Figure 4A and Figure 4B An example of a method for implanting a vascular access device is schematically illustrated;

[0061] Figure 4C An alternative example of a method for implanting a vascular device is shown;

[0062] FIG. 5A to FIG. 5C Another example of a vascular access device is schematically shown; and

[0063] Figure 5D Another variation of a vascular access device is schematically shown.

[0064] The drawings relate to exemplary implementations and are intended only to aid in understanding the claimed subject matter and are not intended to limit the same in any sense. DETAILED DESCRIPTION

[0065] Figures 1A to 1E The implantable vascular access device 10 is schematically shown. The vascular access device 10 comprises a housing and a reservoir 69 having an outlet lumen 37. The vascular access device further comprises a septum 67 for closing the reservoir 69 and defining the injection area 40.

[0066] The device 10 may also include a visualization system for visualizing the injection area 40 and a controller configured to actuate the visualization system. The implantable vascular access device in this example is self-detaching.

[0067] The injection area in this example is substantially oval. Other shapes and sizes can also be used for the injection area 40.

[0068] In this example, the visualization system includes a plurality of light emitting devices arranged along the perimeter of the injection area 40. In this example, a plurality of LEDs 42 are arranged at a relatively short distance from each other so as to be able to illuminate and indicate the perimeter of the injection area. In some examples, the LEDs may have a width or diameter of, for example, 1 mm-4 mm. The spacing of the LEDs may be, for example, 3 mm-10 mm.

[0069] The device may also include an energy source, such as one or more batteries. The controller of the device 10 may be configured to activate the visualization system after receiving an instruction from the remote control. The controller may be configured to activate all LEDs 42 to indicate the injection area after implantation. The electromagnetic radiation emitted by the LEDs 42 may illuminate the patient's skin, and thus the position of the device 10 becomes visible from the outside. In particular, it will be clear to perform an injection from the outside. It is only necessary to perform the injection within the irradiated injection area.

[0070] In an example, LED 42 may be activated for a predetermined period of time, such as between 20 seconds and 2 minutes, or any period of time determined to be sufficient to perform an injection, inject a medication, or draw a blood sample. After the predetermined period of time, LED 42 may be turned off.

[0071] In an example, the LEDs 42 may all be activated in the same way. In other examples, the LEDs may illuminate light of different colors. For example, by selecting the LEDs using different colors, a preferred area for injection may be indicated within the injection area, for example. In one example, all LEDs may be illuminated initially, and after a few seconds, only a selection of LEDs are activated. A center point between the activated LEDs may constitute a "target" or reference for injection. Selectively and temporarily activating the LEDs may reduce battery consumption, and thus increase battery life and the life of the entire device.

[0072] One factor that limits the life of an implanted vascular access device is the septum 67. The septum 67 may typically be made of medical grade biocompatible silicone. Depending on the thickness and total area of ​​the injection area, a predetermined number of punctures may be made before the septum begins to degrade and the vascular access device must be replaced. By spreading the injections throughout the injection area (by subsequently directing different areas within the injection area), scars resulting from successive punctures may be less noticeable and the life of the device may be extended. Alternatively, the injection area may be smaller for a given desired lifespan.

[0073] Despite Figures 1A to 1ENot shown in the illustrated example, other systems or methods for visualizing the location of an implanted vascular access device from the outside may also be used. In an alternative example, the visualization system may include an augmented reality device. For example, a professional (e.g., a doctor or nurse) may wear augmented reality glasses. The glasses may include a suitable camera system. The controller may activate a marker (such as an LED) disposed in the device 10, which may be recorded by a suitable camera system so that a display in the glasses may assist the professional in navigating the correct injection site. In such cases, the marker need not be disposed at or along the periphery of the injection area 40. As long as the augmented reality system is able to recognize the marker, a visual representation of the vascular access device 10 or the injection area 40 may be reproduced.

[0074] The vascular access device 10 may include a first end 30 and an opposing second end 20. An outlet lumen 37 may be provided at the first end 30 of the device 10. At the first end 30, the device also includes a connector 35 for coupling to a catheter. The connector 35 may be made of, for example, titanium or plastic.

[0075] The catheter is not in Figures 1A to 1E shown in Figures 1A to 2C and FIG. 3A to FIG. 3B Schematically shown as catheter 80. Any catheter suitable for this purpose can be used. Vascular access device 10 can be used in conjunction with catheters currently used for the same purpose, for example. The diameter and length of the catheter can be the same as known in the art and can depend on the detailed analysis of the patient. Suitable materials for the catheter include, for example, silicone or polyurethane.

[0076] In examples, one or more eyelets 33 may be provided at the first end 30 of the device 10. The eyelets 33 may be used to suture the device 10 to the tissue at the implantation site. It is contemplated that the size and shape of the vascular access device 10 may be provided so that there is less risk of displacement or "flipping" of the vascular access device 10, particularly in examples where no pocket is formed for fitting the device. However, in some cases, as a precaution, additional sutures may be provided at the eyelets 33 to ensure the correct position and orientation of the device. In other examples, such eyelets (or other features suitable for securing or suturing the device in place) are not required.

[0077] The device may also include one or more sensors for measuring patient parameters. The sensor may be arranged near the second end 40 of the device 10. The sensor may be arranged on or connected to the electronic carrier 66, which is described as a box in this article for the purpose of simplicity. The electronic carrier 60 can be arranged in various positions. In the example shown, a cavity is formed in the housing at the second side 20 of the device 10. The housing may have a tapered portion that gradually reduces the height from the injection area to the end of the device 10. The cavity for mounting the electronic carrier 60 can be provided in the tapered portion.

[0078] The sensors may include, for example, sensors for measuring one or more of body temperature, heart rate, oxygen saturation, and blood glucose. Depending on the type of sensor, the sensor may be arranged in contact with the blood in the reservoir 69. In addition, a timer (e.g., for determining a timestamp for an injection, or a timestamp for activating a visualization system) and a communication system may be included.

[0079] The electronic carrier 66 can be or include a printed circuit board. The electronic carrier can include logic described herein as a "controller" to activate and control the visualization system. The electronic carrier 66 can include a receiver for receiving instructions and can include a transmitter for transmitting data. In particular, the sensor data can be sent to a receiver in a data processing system. The data processing system can be a tablet computer, a smart phone, a general purpose computer, or other. Communication with the vascular access device 10 can be based on, for example, NFC, Wi-Fi, Bluetooth, etc. The electronic carrier 66 can also carry a power source, such as a battery.

[0080] The data processing system may process and / or analyze and / or store and / or visualize and / or forward or otherwise process the data. For example, the data may be stored in a hospital data storage, or may be forwarded to a patient's device (e.g., a smartphone), and may be uploaded to a website portal for consultation by the patient and / or medical professional. Thus, medical records, health information, medications that have been given, or other patient-related information may be stored and retrieved from the patient's device.

[0081] The data processing system can also be configured to transmit one or more instructions to the controller of the implantable vascular access device. The instructions can include a command to transmit data, a command to activate one or more LEDs, a command to transmit battery status, etc. In a specific example, an operator can access an appropriate application on a smartphone and transmit instructions, such as lighting for a fixed or manually variable time period.

[0082] In a further aspect, a kit is provided, the kit comprising an implantable vascular access device according to any embodiment disclosed herein, and a remote control for transmitting one or more instructions to a controller of the implantable vascular access device. The remote control device can be the same data processing system that receives and processes the sensor data. For example, a smartphone or tablet can be used to transmit instructions to the vascular access device to activate a visualization system, transmit measurement data, turn on power, or other. The same device can include an appropriate application for receiving, storing and visualizing, for example, received sensor data. If the received sensor data indicates an abnormality, the same electronic device can even be programmed to generate a warning signal. Such an abnormality can be a malfunction of the device or its sensor, or can be an abnormality in the data indicating a possible health problem for the patient.

[0083] The remote control device can also be a different device. For example, the remote control can be a dedicated device for activating the visualization system, while another electronic device is used for data collection.

[0084] The above-described warning signals may also be generated by the vascular access device when outside of the hospital environment, such as when the patient is at home. The vascular access device may be programmed to determine certain variables (oxygen saturation, heart rhythm, etc.) at regular intervals. If an abnormality is detected, a warning signal may be sent to the medical professional and / or the patient's electronic device.

[0085] In some examples, the electronic carrier may include a GPS or other positioning system so that the patient can be located if a warning signal is transmitted.

[0086] In a further specific example, the remote control may be integrated into the needle. For example, the needle device may first be brought near the patient and a wake-up or activation command is transmitted to the vascular access device 10 for illuminating the injection area 40.

[0087] Figure 1B and Figure 1C Possible dimensions of vascular access device 10 according to one example are shown. Vascular access device 10 may be smaller, in particular flatter, than prior art devices. Vascular access device 10 may also be narrower, ie have a smaller width than prior art devices.

[0088] The height of the device can be 10 mm or less, specifically less than 8 mm, and more specifically 6 mm or less. In some examples, the height of the device can be about the diameter of a catheter to be coupled to the device 10. In an example, the device 10 can be configured to be inaccessible through the patient's skin. The device 10 can be configured to be invisible from the outside when the visualization system is not active.

[0089] exist Figure 1BIn the example shown, the width of the device may be approximately 12 mm.

[0090] For comparison, one of the smallest pediatric vascular access devices available on the market has a height of 11 mm and a width of 23 mm. This is because even the smallest currently available pediatric devices are designed to be palpable, but the examples of the present disclosure do not rely on palpation to identify the position of device 10.

[0091] The device 10 can be formed to have a generally smooth outer surface, i.e., without sharp corners or protrusions. Sharp corners, protrusions, etc. can increase visibility from the outside and help locate the device using palpation, but at the same time can cause problems with irritation, infection, and protrusion through the skin. In such cases, further inventions are needed to replace vascular access devices.

[0092] The injection area may also be as small as possible. In other examples, the injection area may be larger than in the prior art to compensate for any perceived risk by not relying on palpation for positioning the device. The injection area may have a 75 mm 2 or larger, specifically 85mm 2 or larger, more specifically 95mm 2 or larger area. It should be noted that using, for example Figures 1A to 1E The design shown in , can reduce the height and width of vascular access device 10, or even have an increased injection area, compared to prior art devices.

[0093] Figure 1D and Figure 1E The components of a vascular access device according to the illustrated example are schematically shown. The septum 67 may have grooves along its perimeter. The septum 67 may have a smooth and substantially flat top surface, i.e., the ridges or protrusions used in some prior art devices may be avoided.

[0094] An annular electronics carrier strip 48 including a plurality of LEDs fits in the recess to be substantially flush with the top surface of the membrane 67. The electronics carrier strip may be attached to the membrane 67 and housing 64 using, for example, a suitable adhesive.

[0095] Vascular access device 10 may also include a puncture-resistant bowl 68, which may be made of, for example, titanium or plastic. Bowl 68 may be mounted in housing 64. Bowl 68 may have a through hole for fitting connector 35 of a catheter. Housing 64 may include a tapered portion at a second end. Vascular access device 10 may also include a bottom cover 62 to close the device at the bottom side.

[0096] In other examples not shown, the LEDs may be arranged in a different location, such as underneath the bowl 68. The diaphragm 67 and bowl may be transparent so that illumination by the LEDs remains visible from outside the patient.

[0097] In another example, if the injection area can be clearly identified from the outside of the patient's body, the specific position of the LED relative to the injection area and the number of LEDs can be changed. In an example, the flashing, changing colors or other signals of some LEDs can be used to indicate the appropriate puncture site to the medical professional, and the puncture of the needle can be appropriately (e.g., randomly) varied over the injection area.

[0098] A method for locating a vascular access device implanted in a patient may include remotely activating a visualization system of vascular access device 10 to visualize a perimeter of an injection region 40 of vascular access device 10. And the method includes locating vascular access device 10 by detecting the perimeter of injection region 40 while avoiding palpation of the patient.

[0099] In some examples, remotely activating the visualization system may include transmitting an activation signal from one or more of a personal computer, a tablet computer, a mobile phone, a smart phone, or a personal digital assistant.

[0100] FIG. 2A to FIG. 2C Other examples of vascular access devices 10 are shown. Figure 2A The example of corresponds substantially to the example of FIG. 1 , and in particular, Figure 2A Corresponds to Figure 1C .

[0101] Figure 2B and Figure 2C Two alternatives are shown. The height of the two vascular access devices is the same as in the example of FIG1 , i.e. 6 mm. Figure 2B and Figure 2C The length of the tapered section has been increased. Figure 2A In the example of FIG. 5 , the length L of the tapered portion 50 may be approximately 15 mm. Figure 2B and Figure 2C The length of the tapered portion 50 in the example may be 30 mm or more, in particular 40 mm or more. The increase in the length of the tapered portion makes the device more suitable for self-detachment: the gradual increase in height can facilitate the introduction of the device.

[0102] exist Figure 2B In the example of FIG. 4 , both the top and bottom surfaces of the device are tapered toward the end 20. The height of the end 20 substantially corresponds to the middle of the device-side connector 35 for coupling to the catheter.

[0103] exist Figure 2C In the example of , the bottom surface is substantially flat. The top surface tapers toward the bottom.

[0104] In an example, the cone angle of the tapered portion may be 35° or less, specifically 25° or less, and more specifically 15° or less.

[0105] FIG. 3A to FIG. 3C Schematic diagram of a method for delivering a Figures 1A to 1E The device 10 or FIG. 2A to FIG. 2C The delivery system of any example vascular access device. The vascular access device can have a first end 30 and a second end 20, and an outlet lumen 37 having a device-side connector 35 for coupling to a catheter disposed at the first end 30. The delivery system includes a tunneler 100 configured to provide a tunnel between a first access site and a second access site. The tunneler can also be configured to releasably couple to the vascular access device 10 at the second end 20 of the vascular access device, i.e., at an end opposite to the end to which the catheter 80 can be coupled.

[0106] The terms "first" and "second" entry sites do not imply any particular order in which the entries are set up. That is, a first entry site may be created before a second entry site, and vice versa.

[0107] The first entry site is the site where the catheter is initially inserted into a suitable vein, as will be explained in more detail with reference to FIG. 3. The first entry site may be in or near the patient's neck and the patient's subclavian region. In order to position the catheter in the vein, the Seldinger technique may be used. Depending on the circumstances and the system used, the process may include puncturing the skin with a hollow needle to position the catheter in the vein. Using one or more of a sheath, a dilator, and a guide catheter, the catheter to be attached to the vascular access device may be positioned in the vein. Other techniques for accessing the vein may also be used, such as a modified Seldinger technique, a cutback procedure, or an online technique.

[0108] The second access site is a location for introducing or withdrawing the tunneler. The second access site can be closer to the implantation site of the vascular access device. In prior art methods and systems, the second access site typically requires an incision (and subsequent suturing) for separating and forming a pocket of sufficient size for subsequent introduction of the vascular access device. Although examples of vascular access devices can be implanted in the same manner as in the prior art, in other examples, the vascular access device can be implanted in a manner that reduces scarring and reduces the risk of infection, and the vascular access device can be more comfortable for the patient.

[0109] The tunneler can be used to create a subcutaneous tunnel from a first access site to a second access site, or vice versa. The tunneler can also be configured to release a vascular access device at a location between the first access site and the second access site, which will refer to Figure 3A and Figure 3BExplain in more detail.

[0110] The second entry site may be in the axilla. Using examples of the present disclosure, the second entry site may be selected in a different region than prior art methods. The second entry site may be in a more visible region due to less scarring, and this may be more convenient for the surgeon.

[0111] As previously described, tunneler 100 can be configured to be releasably coupled at second end 20 of vascular access device 10, while catheter 80 is coupled at first end 30. Vascular access device 10 has a device-side connector that is releasably coupled to the tunneler. The device-side connector can be an eye or eyelet configured to receive hook 110 of the delivery system. To hook tunneler 100 to vascular access device 10, respectively, the medical professional performing device implantation can open or close the hook.

[0112] In the example shown, the hook can include two parts that, when closed, form a closed loop to hold the eyelet of the vascular access device. The two parts are separable to open the loop so that the eyelet can be removed.

[0113] In another example, the device-side connector can be a connector for magnetic coupling to a connector of a delivery system.The tunneler or device-side connector can have an electromagnet to actively couple the device to the tunneler, and when the device is in place, decoupling can occur.

[0114] Figure 4A and Figure 4B An example of a method for delivering a vascular access device 10 to an implantation site is schematically shown. The method includes providing a first access site 122 through the patient's skin and introducing a catheter 80 through the first access site 122 into a vein.

[0115] The vein into which the catheter 80 may be introduced may be any suitable vein, in particular any of the following: the external jugular vein, the internal jugular vein, the cephalic vein, the subclavian vein and the femoral vein.

[0116] The method may also include providing a second access site 124 through the patient's skin and providing a tunnel between the first access site and the second access site using the tunneler 100 .

[0117] As previously mentioned, numbering an entry site as “second” does not mean that a second entry site is created after the first entry site. A tunnel may be formed by introducing tunneler 100 from the second entry site to first entry site 122.

[0118] As previously described, a variation of the Seldinger technique can be used to position one end of the catheter 80 in the vein. Setting the first entry site can include puncturing through the skin with a hollow needle, wherein the distal end of the hollow needle reaches the vein, and introducing a guide wire into the vein through the hollow needle. Additional sheaths and / or dilators can be used to position the catheter in the selected vein.

[0119] The other end of the catheter can be coupled to a vascular access device, for example, at connector 35. The appropriate length of catheter 80 can be determined based on the selected implantation site of vascular access device 10, and the catheter can be cut to the appropriate length.

[0120] The method then includes releasably coupling tunneler 100 to vascular access device 10 and moving tunneler 100 from first access site 122 toward second access site 124 to pull vascular access device 10 toward second access site 124. That is, in contrast to prior art methods, a vascular access device is introduced into the patient at first access site 122 (the same access site used to position a catheter in a vein) rather than at second access site 124.

[0121] The incision at the second site may be smaller than the incision in the prior art. The length of the incision at the second site may be less than 0.5 cm, specifically less than 3 mm, and more specifically 2 mm or less.

[0122] When vascular access device 10 is pulled by the tunneler, the method includes releasing vascular access device 10 at the implantation site. The tunneler can then be further pulled to exit through the second access site, and the vascular access device remains in place.

[0123] In some examples, setting a tunnel between first access site 122 and second access site 124 and pulling second access site 124 toward vascular access device 10 may be performed simultaneously, ie, the tunnel is formed as vascular access device 10 is pulled due to its self-detaching properties.

[0124] In other examples, tunneler 100 is used to set up a tunnel from a first access site to a second access site, and then tunneler 100 is releasably coupled to a vascular access device and the tunneler is moved from the first access site to the second access site.

[0125] The method may also include visualizing the vascular access device and / or the catheter as the vascular access device is pulled from the first access site to the second access site. Visualization may include visualization using X-rays to ensure that the catheter is correctly positioned and remains correctly positioned. The catheter may include radiopaque markers in appropriate locations. In some examples, the vascular access device may also include radiopaque markers for visualization using X-rays. A certain traction force may be applied to the catheter as the vascular access device is pulled. X-ray visualization may be used to ensure that the catheter stays in the correct position. The ability to correctly position the vascular access device in the correct position is particularly important for children because the size of children can change significantly with age.

[0126] The vascular access device visualization system may also be used during implantation to visualize the injection area, making it clear where future punctures will be made.

[0127] Figure 4C An alternative example of a method for implanting a vascular access device is shown. As explained throughout this disclosure, the vascular access device can be smaller and thinner than prior art devices. A relatively small size device can also be implanted in a patient's arm. One aspect of implanting the device in a patient's arm is that such a procedure can be performed only under local anesthesia without the need for a fully equipped operating room. The vein can be accessed using the Seldinger technique, and a catheter can be advanced in a deep vein in the middle of the arm.

[0128] The catheter can be coupled to one end of the vascular access device, as shown in the previous example.Introduction of the catheter and vascular access device can be performed through a single incision in the arm.

[0129] FIG. 5A to FIG. 5C Another example of a vascular access device is schematically shown. The general terminology of the vascular access device in terms of its size, use, and potential implantation method is similar to the other embodiments shown herein. The materials may also be similar to the examples mentioned above.

[0130] Figure 5A An isometric view of the device is shown. Figure 5B A longitudinal cross-section of the device is shown. Figure 5C An isometric view is shown in which the outer shell of the vascular access device has been removed to show the interior of the device.

[0131] The vascular access device includes a housing and a reservoir having an outlet lumen 37. The vascular access device may include a connector 35 for coupling to a catheter. The reservoir is formed between a bowl 68 and a septum 67. A top region of the septum 67 may define an injection region 40.

[0132] Along the periphery of the membrane 67, a plurality of light emitting devices may be arranged, in particular LEDs 42. In this particular example, the device comprises 14 LEDs.

[0133] As previously mentioned, the LEDs 42 can be selectively activated. For example, a mobile phone or smartphone with Bluetooth technology can be used to establish communication with the device. Once the device "wakes up", all LEDs 42 or a selection thereof can be activated. As previously mentioned, all LEDs can have the same color, or LEDs with different colors can be used. They can be programmed in a suitable manner to allow injections and also change the injection point by indicating to the medical professional which area (within the injection area 40) is preferred for the next injection.

[0134] As mentioned above, the device may have a tapered portion to promote self-separation. In this particular example, the diaphragm 67 is arranged in the tapered portion and forms part of the tapered portion.

[0135] In the example of FIG. 5 , the device may include multiple batteries. Specifically, four batteries are shown. In contrast to the other examples, the bowl 68 is arranged on top of four batteries 71. In the specific example, four 1,4V zinc batteries are shown. For example, Duracell DA 312 batteries may be used.

[0136] Since the bowl 68 is arranged on top of the battery, the height of the bowl 68 can be reduced compared to the previous examples so as not to increase the overall height of the device. Similarly, the connector 35 and the inner cavity 37 are arranged to be higher than other examples.

[0137] The device of FIG. 5 includes an electronic carrier 66, which may be or include a printed circuit board. The electronic carrier may include logic described herein as a "controller" to activate and control the visualization system. The electronic carrier 66 may include Bluetooth technology for communicating with, for example, a smartphone, tablet computer, or other device. The electronic carrier 66 may include one or more sensors, similar to the sensors shown in other examples.

[0138] The device shown in FIG. 5 may have a height of 10 mm, a width of 12 mm, and a length of approximately 40 mm.

[0139] Figure 5D Another variation of a vascular access device is shown. This variation is based on FIG. 5A to FIG. 5C The device shown. Figure 5D In general, it corresponds to Figure 5CIn this example, a tunneler (e.g., tunneler 100 shown in other figures) can be releasably coupled at the second end 20 of the vascular access device 10, while the catheter 80 is coupled at the first end 30. The vascular access device 10 has a device-side connector that is releasably coupled to the tunneler. The device-side connector can be an eye or eyelet or opening configured to receive a hook 110 or other coupling feature of the delivery system. To hook the tunneler 100 to the vascular access device 10, respectively, the medical professional performing the device implantation can open or close the hook.

[0140] Implantation and positioning Figure 5D The vascular access device may be implemented using the method described with reference to FIG. 4 .

[0141] For the sake of completeness, various aspects of the disclosure are set forth in the following numbered clauses:

[0142] Clause 1. An implantable vascular access device comprising:

[0143] shell;

[0144] a reservoir having an outlet lumen;

[0145] a diaphragm for closing the reservoir and defining an injection area;

[0146] a visualization system for visualizing the injection area;

[0147] A controller is configured to activate the visualization system, and wherein the implantable vascular access device is self-detaching.

[0148] Clause 2. The device according to clause 1, wherein the injection area has a 75 mm 2 or larger, specifically 85mm 2 or larger, more specifically 95mm 2 or larger size.

[0149] Clause 3. The device of clause 1 or 2, wherein the height of the device is 10 mm or less, specifically less than 8 mm, and more specifically 6 mm or less.

[0150] Clause 4. The device according to any of clauses 1-3, wherein the housing comprises a tapered portion, and optionally wherein the tapered portion has a length of at least 15 mm, in particular greater than 30 mm.

[0151] Clause 5. The device of any of clauses 1-4, configured to be inaccessible through the patient's skin.

[0152] Clause 6. The device of any of clauses 1-5, wherein the injection area is substantially elliptical.

[0153] Clause 7. The device according to any of clauses 1-6, wherein the visualization system comprises one or more light emitting devices arranged along the perimeter of the injection area.

[0154] Clause 8. The device of any of clauses 1-7, wherein the visualization system comprises an augmented reality device.

[0155] Clause 9. The device of any of clauses 1-8, wherein the visualization system is configured to indicate a circumference of the injection area.

[0156] Clause 10. The device according to any of clauses 1 to 9, further comprising an energy source, optionally a battery.

[0157] Clause 11. The apparatus of any of clauses 1-10, wherein the controller is configured to activate the visualization system upon receiving an instruction from a remote control.

[0158] Clause 12. The apparatus of any of clauses 1-11, wherein the visualization system is configured to be active for a predetermined period of time, and optionally wherein the visualization system is configured to indicate a puncture site within the injection area.

[0159] Clause 13. The device of any of clauses 1-12, wherein the outlet lumen is disposed at a first end of the device, and the device further comprises a device-side connector for releasably coupling to a connector of a delivery system.

[0160] Clause 14. The device of Clause 13, wherein the device-side connector is an eye or an eyelet configured to receive a hook of the delivery system.

[0161] Clause 15. The device of clause 13, wherein the device-side connector is a connector for magnetically coupling to a connector on the delivery system.

[0162] Clause 16. The apparatus of any of clauses 1-15, further comprising one or more sensors for measuring patient parameters.

[0163] Clause 17. The apparatus of any of clauses 1-16, further comprising a transmitter for transmitting data to a receiver.

[0164] Clause 18. A system comprising an apparatus according to clause 16 or 17, further comprising a data processing system comprising a receiver for receiving data transmitted by a transmitter of the apparatus and a database for storing the received data.

[0165] Clause 19. The system of Clause 18, further comprising a display for visualizing the received data.

[0166] Clause 20. The system of clause 18 or 19, wherein the data processing system is a personal computer, a tablet, a mobile phone, a smartphone, or a personal digital assistant.

[0167] Clause 21. The system of any of clauses 18-20, wherein the data processing system is further configured to transmit one or more instructions to a controller of the implantable vascular access device.

[0168] Clause 22. A kit comprising an implantable vascular access device according to any of clauses 1-17, and a remote controller for transmitting one or more commands to a controller of the implantable vascular access device.

[0169] Clause 23. The kit of clause 22, wherein the remote control is a personal computer, a tablet computer, a mobile phone, a smartphone, or a personal digital assistant.

[0170] Clause 24. The kit of clause 22, wherein the remote control is integrated into the needle.

[0171] Clause 25. An implantable vascular access device comprising:

[0172] shell;

[0173] a reservoir having an outlet lumen;

[0174] a diaphragm for closing the reservoir and defining an injection area;

[0175] one or more sensors arranged to measure one or more parameters of the blood in the reservoir; and

[0176] a transmitter for transmitting said measured parameters.

[0177] Clause 26. The device of clause 25, wherein the sensor is configured to measure one or more of: body temperature, heart rate, oxygen saturation, blood glucose.

[0178] Clause 27. The apparatus of clause 25 or 26, further comprising a visualization system for visualizing the injection area and a controller configured to activate the visualization system.

[0179] Clause 28. The apparatus of Clause 27, wherein the visualization system comprises one or more light sources configured to indicate a perimeter of the injection area.

[0180] Clause 29. The device of any of clauses 25-28, wherein the housing comprises a tapered portion, the tapered portion comprising the transmitter and electronic support, and optionally wherein the tapered portion has a length of 15 mm or more, and optionally wherein the tapered portion has one or more tapered angles of 35° or less.

[0181] Clause 30. The device of any of clauses 25-29, configured to be inaccessible through the patient's skin.

[0182] Clause 31. The device of any of clauses 25-30, wherein the injection area is substantially elliptical.

[0183] Clause 32. The device of any of clauses 25-31, wherein an outer contour of the device is substantially smooth.

[0184] Clause 33. A system comprising the apparatus of any of clauses 25-32, further comprising a data processing system comprising a receiver for receiving the parameters transmitted by the transmitter.

[0185] Clause 34. The system of clause 33, wherein the data processing system is a personal computer, a tablet computer, a mobile phone, a smart phone, or a personal digital assistant.

[0186] Clause 35. The system of clause 33 or 34, wherein the data processing system is further configured to transmit one or more instructions to a controller of the implantable vascular access device.

[0187] Clause 36. A method for positioning a vascular access device implanted in a patient, comprising:

[0188] remotely activating a visualization system of the vascular access device to visualize a perimeter of an injection area of ​​the vascular access device, and

[0189] The vascular access device is positioned by detecting the perimeter of the injection area while preventing palpation of the patient.

[0190] Clause 37. The method of clause 36, wherein remotely activating the visualization system comprises transmitting an activation signal from one or more of a personal computer, a tablet computer, a mobile phone, a smart phone, or a personal digital assistant.

[0191] Clause 38. The method of clause 36 or 37, wherein the visualization system is configured to visualize a perimeter of the injection area during a predetermined period of time.

[0192] Clause 39. The method according to any of clauses 36-38, wherein the height of the vascular access device is less than 10 mm, particularly less than 8 mm, and more particularly 6 mm or less.

[0193] Clause 40. The method of any of clauses 36-39, wherein the vascular access device is not visible from outside the patient when the visualization system is not activated.

[0194] Clause 41. A delivery system for delivering a vascular access device, in particular a self-detaching vascular access device,

[0195] The vascular access device has a first end and a second end, and an outlet lumen having a device-side connector for coupling to a catheter disposed at the first end, the delivery system comprising:

[0196] A tunneler configured to provide a tunnel between a first access site and a second access site, wherein

[0197] The tunneler is also configured to releasably couple to the vascular access device at the second end of the vascular access device.

[0198] Clause 42. The delivery system of Clause 41, wherein the tunneler is configured to release the vascular access device at a location between the first access site and the second access site.

[0199] Clause 43. The delivery system of clause 41 or 42, wherein the first access site is in or near the cervical or subclavian region of the patient.

[0200] Clause 44. The delivery system of Clause 43, wherein the second access site is in the axillary region of the patient.

[0201] Clause 45. A method for delivering a vascular access device, particularly a self-detaching vascular access device, to an implantation site:

[0202] providing a first access site through the patient's skin;

[0203] introducing a catheter into a vein through the first access site;

[0204] providing a second access site through the patient's skin;

[0205] using a tunneler to set up a tunnel between the first access site and the second access site;

[0206] releasably coupling the tunneler to the vascular access device and moving the tunneler from the first access site toward the second access site to draw the vascular access device toward the second access site;

[0207] The vascular access device is released at the implantation site.

[0208] Clause 46. The method of Clause 45, wherein placing the tunnel between the first access site and the second access site and drawing the second access site toward the vascular access device are performed simultaneously.

[0209] Clause 47. The method of clause 45, wherein the tunnel is provided from the first access site to the second access site using the tunneler, and wherein the tunneler is subsequently releasably coupled to the vascular access device and the tunneler is moved from the first access site to the second access site.

[0210] Clause 48. The method of any of clauses 45-47, wherein providing the first access site comprises puncturing through the skin with a hollow needle, and wherein a distal end of the hollow needle reaches the vein, and introducing a guide wire through the hollow needle into the vein.

[0211] Clause 49. The method of any of clauses 45-48, wherein providing the second access site comprises making an incision in the skin, wherein the incision is less than 0.5 cm in length, specifically less than 3 mm in length, and more specifically 2 mm in length or less.

[0212] Clause 50. The method of any of clauses 45-49, wherein the tunneler is releasably mechanically coupled to the vascular access device.

[0213] Clause 51. The method of clause 50, wherein the tunneler comprises a hook for coupling with an eye or an eyelet of the vascular access device.

[0214] Clause 52. The method of any of clauses 45-51, further comprising visualizing the vascular access device and / or the catheter while pulling the vascular access device from the first access site toward the second access site.

[0215] Clause 53. The method of clause 52, wherein the visualization comprises visualization using X-rays.

[0216] Clause 54. The method according to any of clauses 45-53, wherein the height of the vascular access device is less than 10 mm, particularly less than 8 mm, and more particularly 6 mm or less.

[0217] Clause 55. The method of any of clauses 45-54, wherein the vascular access device comprises one or more sensors arranged to measure one or more parameters of blood in the reservoir and a transmitter for transmitting the measured parameters.

[0218] Clause 56. The method of any of Clauses 45-55, wherein the vascular access device comprises a tapered portion.

[0219] Clause 57. The method according to clause 56, wherein the tapered portion has a length of 15 mm or more, in particular 30 mm or more.

[0220] Clause 58. The method according to clause 56 or 57, wherein the tapered portion has one or more cone angles of 35° or less, specifically 20° or less.

[0221] Although only a plurality of examples are disclosed herein, other replacements, modifications, uses and / or their equivalents are possible. In addition, all possible combinations of the described examples are also contemplated. Therefore, the scope of the present disclosure should not be limited by the specific examples, but should only be determined by a reasonable reading of the appended claims.

Claims

1. An implantable vascular access device comprising: shell; a reservoir having an outlet lumen; a diaphragm for closing the reservoir and defining an injection area; a visualization system for visualizing the injection area; A controller is configured to activate the visualization system, and wherein the implantable vascular access device is self-detaching. 2 . The device according to claim 1 , wherein the height of the device is less than 10 mm, particularly less than 8 mm, and more particularly 6 mm or less.

3. A device according to claim 1 or 2, wherein the device is configured to be accessible through the patient's skin.

4. The device according to any one of claims 1-3, further comprising a tapered portion, and optionally wherein the tapered angle is less than 35°.

5. The device according to claim 4, wherein the length of the tapered portion is at least 15 mm, in particular greater than 30 mm.

6. The device according to any one of claims 1 to 5, wherein the injection area has a diameter of 75 mm. 2 or larger, specifically 85mm 2 or larger, more specifically 95mm 2 or larger size.

7. The device according to any one of claims 1 to 6, wherein the visualization system comprises one or more light emitting devices arranged along the periphery of the injection area.

8. The apparatus according to any one of claims 1-7, wherein the controller is configured to activate the visualization system after receiving an instruction from a remote control.

9. The device of any one of claims 1-8, further comprising one or more sensors for measuring patient parameters.

10. The device of claim 9, wherein the sensor is configured to measure one or more of the following: body temperature, heart rate, oxygen saturation, blood sugar.

11. The apparatus according to any one of claims 1 to 10, further comprising a transmitter for transmitting data to a receiver.

12. The device of any one of claims 1-11, wherein the outlet lumen is disposed at a first end of the device, and the device further comprises a device-side connector for releasably coupling to a connector of a delivery system.

13. A delivery system for delivering a vascular access device according to claim 12, the vascular access device having a first end and a second end, and an outlet lumen having a device-side connector for coupling to a catheter disposed at the first end, the delivery system comprising: A tunneler configured to provide a tunnel between a first access site and a second access site, wherein The tunneler is also configured to releasably couple to the vascular access device at the second end of the vascular access device.

14. The delivery system of claim 13, wherein the tunneler is configured to release the vascular access device at a location between the first access site and the second access site.

15. A system comprising a device according to any one of claims 1-12, further comprising a data processing system, the data processing system comprising a receiver for receiving data transmitted by the transmitter of the device and a database for storing the received data, wherein the data processing system is optionally a personal computer, a tablet computer, a mobile phone, a smart phone or a personal digital assistant.

Images